MOWI Research Pilot

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot

The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Develop & Refine MOWI w/o Amulet; Behavioral: MOWI Weight Loss Maintenance; Behavioral: Develop & Refine MOWI w Fitbit; Dietary supplement: Develop & Refine MOWI w Fitbit/Protein

Detailed Description

The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity.

Study Timeline:

September 2017 to June 2018:

Goal: Conduct a pilot study of improving weight and physical function in older adults with obesity. An mHealth Obesity Wellness Intervention (MOWI) will integrate Amulet +/- Fitbi with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session.

Participation Duration: Three times weekly for 3 months

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All Aims:

• Age ≥65 years
• Body Mass Index (BMI) ≥ 30kg/m^2
• Waist circumference ≥88cm in females or ≥102cm in males

Aims 2 & 3:

• Have Wi-Fi high speed internet
• Able to obtain medical clearance from doctor
• Have less than a 5% weight loss in past 6 months
• No advanced co-morbidity
• No exercise restrictions
• Not involved in other research studies that may interfere with participation

Exclusion Criteria:

• Severe mental or life-threatening illness
• Dementia
• Substance use
• History of bariatric surgery
• Suicidal ideation
• Unable to perform measures
• Reside in nursing home
• No advanced co-morbidity
• No exercise restrictions
• Not involved in other research studies that may interfere with participation

Aim 4 - had to have completed Aims 2 or 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Develop & Refine MOWI w/o Amulet (2A); Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.	Behavioral: Develop & Refine MOWI w/o Amulet; The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.; Other Names: MOWI 2A
EXPERIMENTAL: MOWI Weight Loss Maintenance; Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.	Behavioral: MOWI Weight Loss Maintenance; Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).; Other Names: MOWI LT
ACTIVE_COMPARATOR: Develop & Refine MOWI w Fitbit (2B); Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.	Behavioral: Develop & Refine MOWI w Fitbit; The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.; Other Names: MOWI 2B-2
ACTIVE_COMPARATOR: Develop & Refine MOWI w Fitbit/Protein (2P); Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.	Dietary supplement: Develop & Refine MOWI w Fitbit/Protein; The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.; Other Names: MOWI Protein-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Grip Strength	Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.	Baseline, 12 weeks
Change in 5 Times Sit-to-Stand (STS)	STS measures lower limb strength (minimal change 2.3 s).	Baseline, 12 weeks
Change in Six-Minute Walk Test (6MWT)	A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m	Baseline, 12 weeks
Change in Gait Speed (m/s)	Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).	Baseline, 12 weeks
Change in Late-Life Function and Disability Instrument (LLFDI)	LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Behavioral Activation (Patient Activation Measure)	Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors & outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation	Baseline, 12 weeks post study
Change in Subjective Health Status (PROMIS) Physical	Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health	Baseline, 12-weeks
Change in Weight in kg	Change in weight in kg	Baseline, 12 weeks
Change in Waist Circumference in cm	Change in waist and hip circumference in cm	Baseline, 12 weeks post study
Average Steps/Expenditure	Average Steps will be measured over a 12 week period	Mean steps over 12 week period of time
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -	Change Score between baseline and 12 weeks
Change in Body Composition - Lean Mass	Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured	Baseline, 12 weeks
Change in Energy Expenditure	Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks	Baseline to 12 weeks
Change in Fasting Plasma Glucose	Fasting Plasma Glucose	Baseline, 12 weeks
Change in Participant Satisfaction Questionnaire Score	The Participant Satisfaction Questionnaire is a 12-item questionnaire which measures participant satisfaction with intervention participation using a Likert scale (0-5 point scale: very unsatisfied = 0 to very satisfied = 4). Total scores range 0-60: higher scores indicate greater satisfaction with the intervention.Three additional sub-items ask participants to rate their preference for the frequency of sessions, length of group meetings, and total number of group meetings using a Likert scale (-1 - 1 point scale: too few/too short = -1 to 1 = too much/too long). Each of these three items will be interpreted individually and not included in a summed total score. Additionally, this questionnaire includes 1 open-ended response item where participants are asked to leave any additional comments they may have regarding their level of satisfaction with the intervention.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI))
Change in Credibility and Expectancy Questionnaire Score	The Credibility and Expectancy Questionnaire is a 6-item questionnaire which measures expectancies regarding intervention participation and intervention rationale credibility using a Likert scale (0-10 point scale: responses are anchored to question stems such that, not at all logical/not at all effective/not at all confident/no credibility/not at all comfortable = 0 and very logical/very effective/very confident/high credibility = 10). Total scores range 0-50: higher scores indicate more favorable expectancies regarding participation in the intervention/greater perceived intervention credibility. Additionally, this questionnaire includes 1 open-ended response item that asks participants to leave any additional comments they may have regarding their expectations for the intervention	Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -	Change Score between baseline and 12 weeks
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -	Change Score between baseline and 12 weeks
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)	CHAMPS is a self-reported tool in older adults that assesses activity levels and types -	Change in KCal between baseline and 12 weeks
Change in Insulin Level	insulin	Baseline, 12 weeks
Change in C-peptide	C-peptide	Baseline, 12 weeks
Change in C-reactive Protein	C-reactive protein	Baseline, 12 weeks
Change in Tumor Necrosis Factor Alpha	tumor necrosis factor alpha	Baseline, 12 weeks
Change in Interleukin 6	Interleukin 6	Baseline, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken	Medication adherence, visual analog scale	Baseline, 12 weeks post study
Change in Food Craving Acceptance and Action Questionnaire Score	The Food Craving Acceptance and Action Questionnaire is a 10-item questionnaire which measures acceptance of food related cravings and urges using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of food related cravings and urges.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in Discomfort Intolerance Scale Score	The Discomfort intolerance Scale is a 6-item questionnaire which measures general difficulty managing and regulating physical distress and discomfort using a Likert scale (1-6 point scale: not at all like me = 1 to very much like me = 6). Total scores range 6-36: higher scores indicate greater distress intolerance.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in Physical Activity Acceptance & Action Questionnaire Score	The Physical Activity Acceptance & Action Questionnaire is a 10-item scale which measures acceptance of physical and psychological discomfort in the context of physical activity using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of physical and psychological discomfort in the context of physical activity.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in Weight Control Strategies Scale Score	The Weight Control Strategies Scale is a 30-item questionnaire which measures participants' use of behavioral weight control strategies using a Likert scale (1-4 point scale: never = 0 to always = 4). Total scores range 0-120: higher scores indicate greater use of weight control strategies.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in Voluntary Exercise Questionnaire Score	The Voluntary Exercise Questionnaire is a brief 6-item questionnaire which measures participants' participation in aerobic and strength training activities over the past 3 months and past week. Two items use a Likert scale (1-7 point scale: never = 1 to 7 = very often) and four items ask participants to report frequency of exercise: 0 = 0 days per week to 7 = 7 days per week). Total score range 2-42: Higher scores indicate greater levels of aerobic and strength training activity.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score	a 24-item assessment of external, introjected, identified, and intrinsic forms of regulation of exercise behavior. Higher scores indicated higher exercise behavior. each is scored on 5 points (0-120). Six subscales - each 4 items (score 0-20 each). A positive change score indicates higher forms of regulation.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in PROMIS Emotional Distress Short Form Score	an 8 item scale used to measure emotional distress/depression. higher score indicates higher distress. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent reduced emotional distress.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in PROMIS Social Isolation Short Form Score	An 8-item scale used to measure perceived social isolation.higher scores indicate higher isolation. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent high isolation.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Change in Three Factor Eating Questionnaire Score	18-item scale measuring eating behavior with 3 subscales (cognitive restraint, emotional eating, uncontrolled eating) using Likert scale (1-4 point scale). Items 1-16 on this scale are reverse scored. The scale score is then entered into the following formula: (cognitive restraint scale score - 3)/9. The outcome is then multiplied by 100. Higher scores indicate higher restraint, emotional eating or uncontrolled eating, respectively. Subscales aretransformed to 0-100 score To calculate the emotional eating sub scale, reverse scored items 2, 4, 7, 10, 14 and 16 are summed and then averaged to generate a mean score. The mean score is then multiplied by 6 to generate a scale score. The scale score is then entered into the following formula: (emotional eating scale score - 6)/18. The outcome is then multiplied by 100. Positive change scores represent lower restraint, higher emotional eating or higher uncontrolled eating.	Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute on Aging (NIA)

Publications and helpful links

General Publications

• Petersen CL, Christensen BC, Batsis JA. Weight management intervention identifies association of decreased DNA methylation age with improved functional age measures in older adults with obesity. Clin Epigenetics. 2021 Mar 2;13(1):46. doi: 10.1186/s13148-021-01031-7.

Helpful Links

• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment
• Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): January 3, 2019
• Study Completion (ACTUAL): January 11, 2020

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: obesity; telemedicine; weight loss; frail elderly; health promotion; rural health
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: D16182_2; K23AG051681 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No